BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3052746 · Received April 11, 2013

    Report

    Report Number
    6000153-2013-00065
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 25, 2013
    Report Date
    March 25, 2013
    Manufacturer
    NEURO - VILLALBA
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT: STYLET ACCESSORY, SERIAL #UNKNOWN. ANALYSIS OF THE STYLET FOUND NO SIGNIFICANT ANOMALY. IT WAS NOTED THAT THE STYLET WIRE WAS BENT. ANALYSIS OF THE LEAD FOUND THAT THE DISTAL END OF THE LEAD WAS BENT. IT WAS NOTED THAT THE OVERALL LENGTH OF THE LEAD WAS 40.5 CENTIMETERS AND THE STYLET DID NOT REACH THE END OF THE LEAD. IT WAS FURTHER NOTED THAT FOREIGN MATERIAL WAS SEEN UNDER THE ELECTRODES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANTATION, THE SURGEON NOTICED A "BENT" CONTACT ON THE LEAD UNDER FLUOROSCOPY. AN ATTEMPT WAS MADE TO IMPLANT THE LEAD BUT IT WAS ULTIMATELY NEVER IMPLANTED CONSEQUENTLY, THE LEAD WAS "REMOVED FROM THE BRAIN" AND REPLACED WITH ANOTHER LEAD. THERE WERE NO PATIENT SYMPTOMS OR INJURIES RELATED TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154896 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY NEURO - VILLALBA 3387S-40 VA055CG

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR